Trial · NCT05535075
Model-informed Precision Dosing of Vancomycin in Adults
NCT05535075, Phase 4, Completed, University Hospital, Ghent
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Model-informed Precision Dosing of Vancomycin in Adults. Trials, record NCT05535075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05535075
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Model-informed Precision Dosing of Vancomycin in Adults
- NCT number
- NCT05535075
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 155 participants, actual
- Lead sponsor
- University Hospital, Ghent
- Conditions
- Vancomycin
- Interventions
- Vancomycin model-informed precision dosing, Vancomycin
- First posted
- 2022-09-10
- Last updated
- 2023-12-01
- Other registries' IDs
- eudract:2021-003670-31
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients reaching target 24h AUC/MIC | 48 to 72 hours after start vancomycin treatment | Therapeutic AUC/MIC target range is 400-600 |
| Secondary | Proportion of patients with (worsening) acute kidney injury (AKI) during vancomycin treatment | From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first | AKI categories are defined according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria from stage 1 to 3 (worst) |
| Secondary | Proportion of patients reaching target 24h AUC/MIC | 72 to 96 hours after start vancomycin treatment | Therapeutic AUC/MIC target range is 400-600 |
| Secondary | Proportion of time within therapeutic target | From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first | Therapeutic AUC/MIC target range is 400-600 |
| Other | Number of (additional) blood samples to first target attainment during vancomycin treatment | From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first | An additional blood sample is defined as a sample for vancomycin TDM taken at another timepoint of routine biochemical monitoring samples. |
| Other | Cumulative number of (additional) blood samples | From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first | An additional blood sample is defined as a sample for vancomycin TDM taken at another timepoint of routine biochemical monitoring samples. |
| Other | Number of dose adjustments to first target attainment | From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first | Target in Model-Informed Precision Dosing arm: 24h AUC/MIC : 400-600; in comparator arm: target concentration range according to institutional guidelines |
| Other | Cumulative vancomycin dose | From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first | Total cumulative exposure (AUC) during treatment |
| Other | Cumulative vancomycin AUC | From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first | Total exposure (AUC) during treatment |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05535075
GET https://conductscience.org/api/trials/v1/NCT05535075/registered